Z-1371-2022Class II

NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate...

Name: Z-1371-2022 NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2022-05-31
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2022-05-31 / Open, Classified / root cause: labeling and UDI

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part... on 2022-05-31. FDA classified it as Class II and gives the reason as "Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1371-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-31
Posted: 2022-07-12
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Fresenius Medical Care issued Urgent Medical Device Recall letter (FA-2022-11-T) dated 6/2/22. Letter states reason for recall, health risk and action to take: These instructions apply only to clinics directly contacted by the Fresenius Medical Care Corrections and Removals Department. " Immediately examine your stock to determine whether you have NaturaLyte Liquid Acid concentrate with the part and lot numbers listed below. " Only bottles with sealed for your protection on the bottle cap foil are affected (see picture below). " Remove the affected product from your inventory. " FMCRTG, LLC will contact you regarding product return. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have any further questions.
Quantity in commerce: 163 cases
Distribution: Natiowide
Product codes and lots: UDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1371-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1370-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12
Z-1371-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12

Product code KPO

K192017Class IICitrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC / cleared 2020-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)